MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack.
FDA device recall Z-0910-2014 · posted 2014-02-03 · Terminated
Recall details
- Recalling firm
- Nipro Diagnostics, Inc.
- Reason for recall
- Manufactured with an incorrect factory set unit of measure.
- Action taken
- Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 105
- Distribution
- Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh,
- Date initiated
- 2013-10-02
- Date posted
- 2014-02-03
- Date terminated
- 2016-01-28
- Location
- Ft Lauderdale, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) (K032657) | Home Diagnostics, Inc. | 2004-03-24 |